Think before you take that pill*

The articles below have being brought together to highlight an area that has not come under much public scrutiny in recent years. This area being prescribed medication and the serve negative impact they can have on a person or as some of the articles below will show the effects they can have on children who’s mothers were on prescribed medication while pregnant.

The articles will also provide insight into why there are rarely independent studies and counter evidence of the effects big pharmaceutical company backed medications have on the people.

We can also see a history of past medications which have being taking off the market, due to the damage they caused, having similarities to medications now being prescribed to millions of people around the world.

Since 2005, the SSRI paroxetine, first marketed by GlaxoSmithKline as Seroxat, has carried warnings of risk of birth defects. In the US litigation in which I have been asked to give evidence, the plaintives will argue that, even before they were launched, there was good laboratory evidence that the SSRIs might cause problems, and, following their initial marketing, evidence emerged over a decade ago from clinical use that the drugs actually do cause problems.

Yet these drugs have been actively promoted, de facto primarily to women of child-bearing years. How could this happen?

Part of the problem is that having gone to their GP with a nervous problem, many women become dependent on a prescribed SSRI and find it impossible to stop using it whether they wish to get pregnant or if they find they are pregnant while on treatment. But few, if any, of these women will have been informed of either the risk of birth defects or the risk of becoming addicted. Why not?

What we are seeing here is the astonishing marketing power of pharmaceutical companies, which can now effect huge changes in medical culture within months. In this case, a great part of the scientific literature (the primary marketing tool of companies) on the use of antidepressants in pregnancy and on dependence on antidepressants is ghostwritten – just as virtually all literature on giving antidepressants to children was, at one point, company-written. Firms of medical writers are contracted to pharmaceutical companies to place in academic journals articles attributed to, but not actually authored by, university researchers.

The process of manufacturing clinical consensus has become so slick that it is now almost impossible to find independent articles from academic physicians with no links to industry that will sound a note of caution about prescribing antidepressants to women of child-bearing years. This is a problem that increasingly applies across all of medicine – from the use of HRT, to drugs for osteoporosis, respiratory or gut problems, pain-relief, as well as all psychotropic drugs.

Where once drugs were seen as poisons to be used judiciously and with caution, they are now treated as fertilisers whose more or less indiscriminate use can only do good. Where once farmers knew to keep their cattle out of fields growing the serotonin reuptake inhibiting weed, St John’s Wort, as it caused miscarriages, under industry influence women have been herded by doctors in exactly the opposite direction.
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GPs are still prescribing an antidepressant known to cause birth defects in unborn children to thousands of women every year, it emerged last night.

Pills such as Seroxat may result in babies being born with malformed hearts if taken in the first few weeks of pregnancy - a time when many women are still unaware they may have conceived.

Several scientific studies have suggested that the class of drugs known as SSRIs, which also includes Prozac, could double the rate of birth defects.

Seroxat is believed to be prescribed to 4 million people in Britain a year and it has been particularly marketed towards women as a drug to relieve anxiety and depression.

But both the Medicines and Healthcare products Regulatory Authority (MHRA) and the National Institute for Clinical Excellence (NICE) watchdogs have warned of the drug’s potential dangers and urged GPs not to prescribe them to pregnant women unless completely necessary.

Last night leading doctors warned that the pills were still being routinely handed out to mothers-to-be and women of a childbearing age without warning of the risks.

Dr Kendall told the Guardian: “But in primary care it is still quite widely prescribed. GPs are quite flooded with advice. It is unlikely they will have picked up a specialist piece of advice from Nice about mental health.”

American doctors have been given strict instructions by the Food and Drug Administration “not to prescribe Paxil (Seroxat) in women who are in the first three months of pregnancy or are planning pregnancy, unless other treatment options are not appropriate”.

A series of legal actions is about to begin in the US against GlaxoSmithKline, the British manufacturer of Seroxat.

Lawyers representing the women involved claim the drugs firm knew about the birth defects 10 years ago - but GlaxoSmithKline deny this is the case.

David Healy, professor of psychiatry in Bangor, Wales, who will give evidence in the US cases, said the rate of birth defects is doubled from 2 per cent in the general population to 4 per of those on the drugs.

The rate of major defects rises from 1 per cent to 2 per cent for women on Seroxat while the rate of miscarriages also doubles from 8 per cent to 16 per cent.

Mr Healy said: “From the late 1980s there was work which very clearly showed that the SSRI group of drugs ought to be regarded as posing a high risk of birth defects to women in the early stages of pregnancy or when they didn’t even know they were pregnant,”

Emily Jackson, professor of law at the London School of Economics, said the cases could potentially be brought against either the GP or the manufacturer for a failure to warn of potential risks.

In 2006 researchers in Toronto found that women prescribed Seroxat and Prozac could be twice as likely to give birth to stillborn or underweight babies.

A study by the Ottawa Research Institute claimed that the products can increase the risk for a range of problems, including premature birth and seizures in newborns.
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The best-known example of birth defects being caused by hazardous substances in the UK remains the babies born in the late 1950s and early 1960s with deformities caused by their mothers taking the drug thalidomide.

It was hailed as a “wonder drug” to treat conditions such as insomnia, morning sickness and depression and licensed in the UK in 1958. But it was withdrawn again in late 1961 after an Australian doctor told the Lancet he had identified an increase in the number of deformed babies born in his hospital, and found that all of the mothers involved had used the drug.

By then around 10,000 babies had been born worldwide who either had shortened arms or legs, or no limbs at all. A few of these “thalidomide children” won damages in 1968 and the rest were covered by a 1973 out-of-court settlement with Distillers, who made the drug. That compensation was later increased, though, after media attention and pressure from some of the firm’s shareholders. Distillers and subsequently Guinness, which bought it, have had to improve the terms of the settlement several times and have paid or agreed to pay around £200m in total up until 2037 to the Thalidomide Trust, which distributes annual payments to the 455 people in Britain damaged by the drug.

Young adults taking antidepressants have twice the risk of suicidal thoughts or behaviour as those taking ‘dummy’ pills, research has shown.

Adults aged under 25 were as much at risk as children and adolescents, according to a review of more than 100,000 patients in the British Medical Journal.

Researchers analysed 372 studies and looked at 12 anti-depressants, including selective serotonin reuptake inhibitors (SSRIs) such as Prozac and Seroxat.

Professor John Geddes, from Oxford University, said in an editorial in the BMJ that there were also important differences emerging between anti-depressants.

‘The odds of suicide behaviour on sertraline [an SSRI], for example, is around half that on placebo,’ he said.

‘It is becoming apparent that anti-depressants vary in both their efficacy and adverse effects.’

Doctors are advised not to prescribe many anti-depressants to under-18s, and instead to recommend cognitive therapy, which teaches patients to change behaviour patterns.

Suicide warnings are now included on medication in the U.S. and the British drug safety watchdog advises doctors to ‘carefully monitor’ young adults during treatment for any worsening of symptoms of suicidal behaviour.

Doctors are advised not to prescribe the majority of SSRIs to under-18s and NHS guidelines recommend cognitive therapy, which teaches patients to change behaviour patterns, as first-line treatment for mild to moderate depression.

The researcher who led the review, Dr Marc Stone of the U.S. FDA, said the increased suicidal risk was greatest in young people with psychiatric disorders other than depression.

He said ‘The findings support the idea that antidepressant drugs can have two separate effects: an undesirable effect in some patients that promotes suicidal thoughts or behaviour, with a risk that appears to diminish with age, and protective effect in others that alleviates depression and reduces any suicidal risk.’

Latest figures show in the UK in 2007 there were 34 million prescriptions for antidepressants, of which 18 million were for SSRIs.